Naproxen/diphenhydramine

Naproxen/diphenhydramine

Combination of
Naproxen	NSAID
Diphenhydramine	Antihistamine
Clinical data
Trade names	Aleve PM, others
AHFS/Drugs.com	Aleve-PM
License data	US  DailyMed:  Diphenhydramine hydrochloride and naproxen sodium
Routes of administration	By mouth
ATC code	R06AA52 ( WHO ) M01AE57 ( WHO )
Legal status
Legal status	CA: OTC [1] US: OTC [2]

Naproxen/diphenhydramine, sold under the brand name Aleve PM among others, is a formulation of naproxen with diphenhydramine marketed by Bayer Healthcare. ^[2] It is available over-the-counter. The intended use of the drug is relieve pain specifically when going to sleep. ^[3]

Adverse effects

See also: Naproxen § Adverse effects, and Diphenhydramine § Adverse effects

Women in the third trimester of pregnancy should avoid this drug because there is a risk that naproxen, like other NSAIDs, may cause premature closure of the ductus arteriosus. ^[3]

In October 2020, the US Food and Drug Administration (FDA) required the prescribing information to be updated for all nonsteroidal anti-inflammatory medications to describe the risk of kidney problems in unborn babies that result in low amniotic fluid. ^{[4] [5]} They recommend avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy. ^{[4] [5]}

References

1. "Product information". health-products.canada.ca. 24 February 2016. Retrieved 18 October 2025.
2. "Aleve PM- diphenhydramine hydrochloride and naproxen sodium tablet, film coated". DailyMed. 6 December 2024. Retrieved 18 October 2025.
3. Michele TM (16 January 2014). "Summary Review for Regulatory Action: Naproxen/diphenhydramine" (PDF). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on 22 March 2016. Retrieved 21 April 2016.
4. "FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications". U.S. Food and Drug Administration (FDA) (Press release). 15 October 2020. Archived from the original on 16 October 2020. Retrieved 15 October 2020. This article incorporates text from this source, which is in the public domain .
5. "NSAIDs may cause rare kidney problems in unborn babies". U.S. Food and Drug Administration (FDA). 21 July 2017. Archived from the original on 17 October 2020. Retrieved 15 October 2020. This article incorporates text from this source, which is in the public domain .